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Importing Supplements into Japan: A Step-by-Step Guide

Importing Supplements into Japan: A Step-by-Step Guide

Dietary supplements in Japan were only niche products a short while ago. As consumers become more health conscious, these products have become increasingly popular in Japan. Now, imports are expected to rise by 2.2% annually and reach 9.99 million kilograms by 2026.

That makes it an exciting business opportunity for foreign brands of food and dietary supplements.

However, given the legal complexities of supplements in Japan, we will explain what to consider when importing and selling them.

What are Food and Dietary Supplements in Japan?

Navigating import regulations in Japan can be challenging because of its unique perspective on food and dietary supplements. Unlike many countries, Japan does not have a legal definition of food and dietary supplements. Instead, supplements can fall under the category of foods, quasi-drugs, or drugs.

Japanese people purchase food and dietary supplements to add nutrients to their diets, such as vitamins and minerals. Supplements typically come in capsules or tablets.

Important: Is your supplement considered a drug or food in Japan?

You must look at various factors to classify a supplement as a food product, quasi-drug, or drug. These include the product’s ingredients, form, purpose, indications, dosage, sales method, and presentation. The MHLW (Ministry of Health, Labor and Welfare) provides key guidelines for drugs and foods. These lists specify whether certain ingredients are medical, prohibited, or non-medical in Japan.

If a supplement is sold as a food product overseas, it could be deemed a drug or quasi-drug in Japan, depending on its ingredients and dosage. Consequently, the import process would look different. It is best to consult an expert to determine which category your supplements fall into and how to import them. That way, you can avoid customs issues.

This article looks at the import of food and dietary supplements categorized as foods in Japan.

Read more about importing quasi-drugs and drugs into Japan.

How to Import Food and Dietary Supplements Into Japan?

Dietary supplements categorized as foods are governed under the general food laws stated in the Food Sanitation Law, Health Promotion Act, Nutrition Labeling Standards, and the Food Labeling Act. Moreover, you will need the help of an Importer of Record for import compliance, the required paperwork, and payment of import taxes to get your product cleared by customs.

Step 1: Import Application

Japan’s Food Sanitation Law requires you to notify the MHLW before your products enter the market. That involves sending an import application to the quarantine station at the port where your items will arrive. The MHLW will check your supplements and their documentation at the quarantine station for compliance with Japanese laws.

Documents required for your import application:

– Material/ingredient table listed by percentage (in English or Japanese)

– Production flowchart

– Manufacturing plant information

– Table of lab testing results issued by a designated inspection institute of MHLW

– Invoice

– Packing list

– Bill of lading (B/L) or airway bill

Step 2: Product Labelling

The Consumer Affairs Agency (CAA) regulates food labeling in Japan. Therefore, you will need a local expert in most cases to create a compliant label for your supplements. Generally speaking, labels for food products imported into Japan must be in Japanese and include the following:

– Product Name

– Country of Origin

– Ingredients

– Contact Information of the Importer

– Expiration Date

– Storage Method

Additives: In Japan, eight categories of additives must be clearly marked on the label. That includes sweeteners, antioxidants, artificial colors, color formers, preservatives, whiteners, thickeners/stabilizers/gelators/bodying agents, anti-fungal compounds, and antimold substances.

Mandatory Allergen Labelling: Potential allergens like egg, milk, wheat, shrimp, crab, buckwheat noodles, and groundnuts must be labeled.

Recommended Allergen Labelling: It’s advised to label bearded clams, squid, salmon roe, orange, kiwi fruit, beef, walnut, salmon, mackerel, soybean, chicken, banana, pork, matsutake, peach, yam, apple, and gelatin as allergens.

– Content Weight: The label should clearly indicate the product weight in grams or liters.

Nutrition Facts: The label should disclose every nutritional component and calorie count. Also, it should include calories, protein, fat, carbohydrate, sodium, and any other nutritional components that need labeling.

Organic Labelling

Only JAS-certified organic products can be labeled “organic”. That means even if your supplements are considered organic in your country, they will need a JAS certification to carry the label “organic” in Japan.

Labeling Health Benefits

The CAA oversees the labeling of foods with health benefits. These labels are on a spectrum between food and pharmaceutical products in Japan. Consult an expert to determine whether your supplement can carry certain health claims on its label.

The 3 types of health benefits labels are:

1- Foods for Specified Health Uses (FOSHU): FOSHU ingredients are certified to impact specific body functions positively. It’s a label for a broad spectrum of products, from dietary supplements to regular items like tea, juice, soy milk, yogurt, cooking oil, soups, chewing gum, and cereals.

2- Foods with Nutrient Function Claims (FNFC): FNFC ingredients encompass 20 nutrients, such as vitamins, minerals, and fatty acids. Mostly seen in dietary supplements, these nutrients complement a diet.

3- Foods with Function Claims: These are the food products that actively impact the whole body and overall health supported by scientific research, with the responsibility lying to the business operators.

Step 3: Quarantine and Cargo Inspection

When your cargo touches Japanese soil, it’s moved to a specific bonded area. Here, your import application needs to reach the right quarantine station. If your supplements involve ingredients from agricultural or livestock sources or contain certain additives or flavors, seeking prior consultation is advisable. You can contact the Animal Quarantine Service or the Plant Protection Station for additional information to ensure a smooth import process.

An inspection is not always a must. However, don’t be surprised if the quarantine station inspectors decide to conduct one based on your imported products and documentation to ensure they meet Japan’s food standards.

Step 4: Ship to the Final Destination

Once you receive import approval from the quarantine station, your imported supplements are ready to proceed through customs and be shipped to the final destination.

Conclusion

Understanding the import procedures for supplements into Japan helps you enter the market successfully. First, you will need to determine if your supplement is a drug, quasi-drug, or food to know what import procedures you must follow. That will help confirm your product is compliant and avoid delays or problems at customs. Working with local partners can ensure a smooth import procedure.

Do you Want to Enter the Supplement Market in Japan?

With COVUE, you will get a local partner on your side who can guide you step-by-step through the import process. From import compliance to logistics, we can help you enter the Japanese market without any hassle.

Sources: Trade Government, Jetro, Food Compliance International, Gourmet Pro, Opas, CAA